The effect of memantine on improving cognitive deficits and quality of life and reducing the negative symptoms of schizophrenia
Design
Phase 3 A clinical trial with a control group, with parallel groups, double-blind, randomized, selected on 40 patients over a period of 12 weeks. Random number argument will be used to create a random sequence. Numbers
Pairs will be assigned to the intervention group and odd numbers to the control group
Settings and conduct
The study in Zanjan Hakim Center,Samples will be Simple random method assigned to the intervention and control groups.a sample size of 40 patients with schizophrenia will be performed for 12 week
Participants/Inclusion and exclusion criteria
Inclusion :
patients with diagnostic criteria (DSM-5) of schizophrenia and at least two years after diagnosis
Age 18 to 50 years
Receive a fixed dose of antipsychotics for at least 8 weeks and for 4 weeks
before enrollment
Continue treatment with at least one antipsychotic drug during the study
Exclusion:
Outstanding neurological or organic disease in clinical & laboratory studies
Another diagnosis in axis I
Coexistence with mental retardation
Drug addiction or abuse (except nicotine and caffeine)
Inability to communicate
High risk of suicide
Receive ECT in the last two weeks
History of memantine sensitivity
kidney disease
Pregnancy & lactation
Do not use safe contraception in women
Intervention groups
In addition to routine treatment for schizophrenia, memantine tablets will be prescribed for the intervention group.Treatment with 5 mg memantine will be started first and increased 5 mg weekly to 20 mg, then the 20 mg dose will be continued for two months.The control group will receive a placebo in addition to the routine treatment
Main outcome variables
Cognitive assessment, quality of life and negative symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200918048751N1
Registration date:2020-10-30, 1399/08/09
Registration timing:prospective
Last update:2020-10-30, 1399/08/09
Update count:0
Registration date
2020-10-30, 1399/08/09
Registrant information
Name
Alireza Armanikian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3301 8149
Email address
dr.armmani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-10, 1399/08/20
Expected recruitment end date
2021-01-09, 1399/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of memantine in improving cognitive deficits, quality of life and reducing the negative symptoms of schizophrenia patients
Public title
The effect of memantine in improving cognitive deficits, quality of life and reducing the negative symptoms in schizophrenic patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having diagnostic criteria (DSM-5) for patients with schizophrenia and at least two years after diagnosis
Age 18 to 50 years
Receive a fixed dose of antipsychotic for at least 8 weeks and for 4 weeks before enrollment
Continue treatment with at least one antipsychotic drug during the study
Exclusion criteria:
Outstanding neurological or organic disease in clinical and laboratory studies
Existence of another axis-based diagnosis (DSM-5)
Coexistence with mental retardation
Drug addiction or abuse (except nicotine and caffeine)
Inability to communicate
High risk of suicide
Receive ECT in the last two weeks
History of memantine sensitivity
Having kidney disease
Pregnancy and lactation
Do not use safe contraception in women
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible individuals will be randomly assigned to two groups. For this purpose, first a random sequence will be created from the table of random numbers. Then the extracted even numbers will be assigned to the intervention group and the odd numbers will be assigned to the control group. This process will continue to reach the sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and research physicians will not be aware of the distribution of the drug and placebo, which are similar in color, size, shape, and odor to the original drug. To hide the drugs and placebo will be placed in a sealed matte envelope numbered in a row. Envelopes will be prepared by a non-research person.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of zanjan University of Medical Sciences
Street address
Therapeutic and Psychiatric Center, Ark Square, Shahid Dr. Beheshti Educational
City
Zanjan
Province
Zanjan
Postal code
45136-15788
Approval date
2020-08-15, 1399/05/25
Ethics committee reference number
IR.ZUMS.REC.1399.191
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20.9
ICD-10 code description
Schizophrenia, unspecified
Primary outcomes
1
Description
attention of schizophrenic patients
Timepoint
In two time periods before starting the drug and 12 weeks after starting the drug
Method of measurement
Strop computer test
2
Description
executive performance
Timepoint
In two time periods before starting the drug and 12 weeks after starting the drug
Method of measurement
London Tower Computer Test
3
Description
processing speed
Timepoint
In two time periods before starting the drug and 12 weeks after starting the drug
Method of measurement
Strop computer test
Secondary outcomes
1
Description
negative symptoms
Timepoint
In the three time periods before, 8 and 12 weeks after the start of the intervention
Method of measurement
Negative Symptoms Assessment Scale
2
Description
the quality of life
Timepoint
Three time periods before, 8 and 12 weeks after the start of the intervention
Method of measurement
Specific quality of life questionnaire for schizophrenic patients
Intervention groups
1
Description
Intervention group: In addition to the routine treatment of schizophrenia (which includes one of the three antipsychotic drugs: clozapine, risperidone, olanzapine), Sobhan Company Memantine will be prescribed for three months. For this purpose, treatment with 5 mg memantine will be started and 5 mg weekly will be increased to 20 mg, then the 20 mg dose will be continued for two months.
Category
Treatment - Drugs
2
Description
Control group: In addition to routine treatment, the control group will receive a placebo. Routine treatment that includes one of three antipsychotic drugs: clozapine, risperidone, olanzapine. The follow-up period in the present study is 12 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hakim Maintenance Center
Full name of responsible person
Armani Kian Alireza
Street address
5 km of Tabriz road (Amadgah road) nursing home for the disabled and the elderly. The first building. Hakim Center
City
Zanjan
Province
Zanjan
Postal code
4537157451
Phone
+98 24 3354 1754
Fax
Email
reyhane.jozghanbari@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Shaghli Alireza
Street address
Zanjan University of Medical Sciences.,Professor Yousef Sabouti Boulevard
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3301 8687
Email
info@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Joz Qanbari Reyhaneh
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Shahid Dr. Beheshti Educational, Therapeutic and Psychiatric Center., Ark Square
City
Zanjan
Province
Zanjan
Postal code
4513615788
Phone
+98 24 3354 2403
Email
reyhane.jozghanbari@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Armani kian Alireza
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Deputy of Treatment., third floor., Bustan 2 .,University of Medical Sciences ., above Ayatollah Hospital ., Gavazang Road
City
Zanjan
Province
Zanjan
Postal code
4513956111
Phone
+98 24 3301 8000
Email
dr.armmami@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Armani kian Alireza
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
third floor., Deputy of Treatment., Bustan 2.,University of Medical Sciences., above Ayatollah Mousavi Hospital.,Gavazang Road
City
Zanjan
Province
Zanjan
Postal code
4513956111
Phone
098 24 3301 8000
Email
dr.armmani@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to the dissatisfaction of the participants, a decision was made not to publish